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For 2nd time in 2 days, FDA gives emergency clearance to COVID-19 antiviral pill

For 2nd time in 2 days, FDA gives emergency clearance to COVID-19 antiviral pill
Merck says the pill will be available by prescription only and should be administered quickly after being diagnosed with the virus. Photo courtesy Merck

Dec. 23 (UPI) -- For the second time in as many days, federal regulators on Thursday granted emergency approval to an antiviral pill as a treatment for COVID-19 -- this one from Merck, which is expected to be a secondary weapon in fighting the pandemic.

The Food and Drug Administration gave emergency use authorization to Merck's molnupiravir after many months of study of its effectiveness in patients with COVID-19.

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Molnupiravir will be made available for adults and persons considered to be at high risk of severe COVID-19, hospitalization and death. Merck says the pill will be available by prescription only and should be administered quickly after being diagnosed with the virus.

"Today's authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement Thursday.

Merck's molnupiravir is expected to be a secondary option to Pfizer's Paxlovid -- given that studies have shown that molnupiravir is less effective and has potential for more serious side effects, like birth defects. File Photo by Justin Lane/EPA-EFE
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"Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death."

"The agency has also determined that the known and potential benefits of molnupiravir, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks of the product," the FDA said in a statement.

Thursday's authorization came one day after the FDA granted the same emergency authorization to Paxlovid, a competing antiviral tablet produced by Pfizer and Ridgeback Biotherapeutics. It was the first pill to receive FDA authorization to treat COVID-19.

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Merck's molnupiravir, however, is expected to be a secondary option to Pfizer's Paxlovid -- given that studies have shown that molnupiravir is less effective than Paxlovid and has potential for more serious side effects, such as birth defects.

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